Shandong Taibang Biological Products has received approval from the China State Food and Drug Administration (SFDA) to begin trials for its human fibrinogen to be used to treat congenital fibrinogen deficiency and acquired fibrinogen deficiency.
The company can begin with the Phase III clinical trials, which include the efficacy study, since Phases I and II are not required for the product.
Human fibrinogen is indicated for the treatment of congenital fibrinogen reduction or deficiency and acquired fibrinogen deficiency associated with serious liver damage, cirrhosis, disseminated intravascular coagulation, or coagulation disorder.
Shandong Taibang Biological Products is the indirectly owned subsidiary of China Biologic Products.
China Biologic president and chief executive officer Chao Ming Zhao said the new product will advance the company's plasma protein development pipeline.
"The Phase III clinical trials are expected to last about two years, after which we will begin commercial production and sales, assuming the clinical trials prove that the product provides the safe and effective treatments we expect," Zhao added.
